Medidata Medidata

Nordic BioScience

Nordic Bioscience Targets 20 Percent SDV with Risk-Based Monitoring to Streamline Clinical Trial Execution

Summary

Nordic Bioscience, one of the fastest-growing biotech companies in Europe, adopted Rave EDC when it outgrew its homegrown electronic data capture (EDC) system. While exploring Rave EDC, Nordic realized it could also benefit from Rave TSDV. Nordic was already implementing reduced source document verification (SDV), routinely applying 50 percent SDV in most of its clinical trials, but Nordic’s teams were burdened by a highly manual process. 

Moving from reduced monitoring to true risk-based monitoring could enable Nordic to further reduce its SDV to 15–20 percent, which could yield significant cost savings while increasing data quality in compliance with FDA’s new guidelines on risk-based monitoring. Nordic adopted Rave TSDV to streamline reduced SDV in a global study—over 40 sites across Eastern Europe, Asia, Latin America, and the United States. Within that study, Nordic piloted a risk-based monitoring approach in Denmark, using a centralized monitoring strategy that identified emerging trends and potential high-risk areas. 

Powered by Rave TSDV, Nordic made real-time adjustments to SDV requirements, prospectively or retrospectively, at the geography, site, or subject level. Eliminating manual comparison, tracking, and reporting in SDV execution improved efficiency and eliminated human errors inherent in manual processes. Nordic expects to further reduce its SDV coverage from today’s 50 percent to its target of 15–20 percent by fully leveraging risk-based SDV. This has potential to save millions of dollars per study.

Moving from reduced monitoring to true risk-based monitoring could enable Nordic to further reduce its SDV to 15–20 percent